NCT03043729 is a Phase 2 clinical trial of Oxaliplatin in Rectal Cancer, sponsored by AIO-Studien-gGmbH.

Who is sponsoring NCT03043729?

NCT03043729 is sponsored by AIO-Studien-gGmbH.

What drugs are being tested in NCT03043729?

Interventions in NCT03043729: Oxaliplatin, 5-FU, Leucovorin, Aflibercept.

What condition does NCT03043729 study?

NCT03043729 studies Rectal Cancer, Rectosigmoid Cancer.

Is NCT03043729 still recruiting?

NCT03043729 is currently completed. Last updated 6 February 2023.

Last reviewed 2023-02-06 · How we verify

NCT03043729

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

Completed Phase 2 Last updated 6 February 2023

What this trial tests

Phase 2 trial testing Oxaliplatin in Rectal Cancer in 119 participants. Completed in 1 June 2022.

Timeline

6 March 2017

Primary endpoint
11 January 2021

1 June 2022

Quick facts

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	119
Start date	6 March 2017
Primary completion	11 January 2021
Estimated completion	1 June 2022
Sites	1 location across Germany

Drugs / interventions tested

Oxaliplatin (Oxaliplatin) — full drug profile →
5-FU
Leucovorin (leucovorin) — full drug profile →
Aflibercept (AFLIBERCEPT) — full drug profile →

Conditions studied

Rectal Cancer — all drugs for Rectal Cancer →
Rectosigmoid Cancer — all drugs for Rectosigmoid Cancer →

Sponsor

AIO-Studien-gGmbH — full company profile →

Who can join

18 and older, any sex, with Rectal Cancer or Rectosigmoid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Neoadjuvant Chemotherapy without Radiation in Colorectal Cancer.
Bhudia J, Glynne-Jones R, Smith T, Hall M. · · 2020 · cited 9× · PMID 32968364 · DOI 10.1055/s-0040-1713746
mFOLFOX6 versus mFOLFOX6 + aflibercept as neoadjuvant treatment in MRI-defined T3-rectal cancer: a randomized phase-II-trial of the German Rectal Cancer Study Group (CAO/ARO/AIO 0214).
Hofheinz RD, Herrle F, Dechow T, von Weikersthal LF, et al · · 2024 · cited 3× · PMID 39260162 · DOI 10.1016/j.esmoop.2024.103703

Verify or expand the search:

Other trials of Oxaliplatin

Trials testing the same drug.

NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting

Other recruiting trials for Rectal Cancer

Currently open trials in the same condition.

NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07537998 — Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a · Phase 2, PHASE3 · recruiting
NCT07501845 — Registry Maastro Applicator · recruiting
NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting

Other AIO-Studien-gGmbH trials

Trials by the same sponsor.

NCT05510895 — Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer · Phase 2 · completed
NCT05190263 — Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma · completed
NCT04727541 — Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer · Phase 2 · terminated
NCT04172467 — Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients · completed
NCT04221529 — Patients With ES-SCLC and ECOG PS=2 Receiving Atezolizumab-Carboplatin-Etoposide · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03043729 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AIO-Studien-gGmbH
Last refreshed: 6 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03043729.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing